Maestro 1.1 Post-Market Registry

Part of paid clinical trials in Denver, Colorado.

Sponsor
Moon Surgical
Study ID
NCT06103136
Status
Recruiting
Apply to this trial

Conditions

  • Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Laparoscopic surgery using the Maestro Platform — DEVICE
    Patients scheduled for laparoscopic surgery will be operated on as per standard of care, using standard port, surgical table and instrument placements (following local applicable guidelines), and off-the-shelf surgical equipment. Standard of care surgical technique following local applicable guidelines will be used. The Maestro Platform may be used to position and hold the scope as well as the retractor in the locations determined by the surgeon during the procedure, with the ability to revert at any time to standard of care (manual minimally invasive surgery) without the usage of the Maestro Platform, or to convert to open surgery.

Study Details

The objective of the study is to observe the real-life usage of the Maestro Platform for surgical assistance in laparoscopic surgery.

Key Dates

Start date
Sep 29, 2023
Status verified
Feb 2025
Primary completion
Oct 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: Patients operated using the Maestro platform
  • Arm: Control

Primary Outcome Measure

Adverse Events (AEs) in terms of type (device/procedure related), seriousness, level of severity. Rate of occurence of intra-procedural and post-procedural adverse events, and device related complications [ Time Frame: Adverse Events (AEs) in terms of type (device/procedure related), seriousness, level of severity. Rate of occurence of intra-procedural and post-procedural adverse events, and device related complications [ Time Frame: 30 days ] ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Rose Medical CenterDenverColorado80220
Michael Snyder, MD, FACS
Lee HealthFort MyersFlorida33907
Thomas Bass, MD, FACS
Baptist HealthJacksonvilleFlorida32207
Steven Hodgett
Baptist Medical Center BeachesJacksonvilleFlorida32250
Thomas Austgen, MD, FACS
Orlando Veterans Affairs Medical CenterOrlandoFlorida32827-5812
Jessica Feranec, MD, FACOG
Surgeon's Point ASCCedar ParkTexas78613
Eric Acheson, MD, FACS

Find similar trials in Denver, CO

By research site
Rose Medical Center· Denver, COLee Health· Fort Myers, FLBaptist Health· Jacksonville, FLBaptist Medical Center Beaches· Jacksonville, FLOrlando Veterans Affairs Medical Center· Orlando, FLSurgeon's Point ASC· Cedar Park, TX

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